Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K050401 |
Device Name |
CERAMAGE |
Applicant |
SHOFU DENTAL CORP. |
1225 STONE DR. |
SAN MARCOS,
CA
92078
|
|
Applicant Contact |
DAVID MORAIS |
Correspondent |
SHOFU DENTAL CORP. |
1225 STONE DR. |
SAN MARCOS,
CA
92078
|
|
Correspondent Contact |
DAVID MORAIS |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 02/17/2005 |
Decision Date | 04/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|